Associate II, Compliance

Select how often (in days) to receive an alert:
Create Alert

Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

We are seeking a highly motivated and detail-oriented Compliance Associate II to support and strengthen our Quality Management System (QMS) and site compliance programs. This role plays a critical part in maintaining regulatory compliance, driving quality system effectiveness, supporting inspection readiness, and ensuring adherence to cGMP requirements.

As a key member of the Quality organization, you will independently manage quality system processes, including Deviation Management, Change Control, and Cleaning Validation, while partnering with cross-functional teams to promote continuous improvement and inspection readiness across the site.

• Independently manage and perform preliminary assessments for deviations within Track Wise.
• Independently review and manage change controls and facilitate Change Review Board (CRB) meetings to ensure effective evaluation and implementation of proposed changes.
• Monitor deviation and change control life cycles to ensure timely investigations, extensions, approvals, and closures.
• Collaborate with cross-functional teams to drive quality events to completion and maintain compliance with established procedures.
• Ensure compliance with Data Integrity (ALCOA+) principles across investigations, validation documentation, and GMP records.

• Collect, analyze, trend, and report quality metrics related to deviations and change controls on a monthly, quarterly, and annual basis.
• Identify recurring compliance risks, emerging trends, and improvement opportunities.
• Escalate significant findings and recommend corrective and preventive actions.
• Prepare quality summaries and presentations for Quality Management Reviews (QMRs) and leadership meetings.

• Maintain and oversee the site's Cleaning Validation Program.
• Develop and maintain the Cleaning Validation Master Plan (CVMP).
• Support the lifecycle management of cleaning validation activities, including:
  • Initial validation
  • Periodic review
  • Revalidation strategies
  • Continued verification activities
• Design, review, and approve cleaning validation protocols and reports.
• Conduct risk assessments for cleaning processes and validation activities.
• Evaluate:
  • Worst-case product selection
  • Sampling strategies (swab and rinse)
  • Analytical methods
  • Acceptance criteria
• Ensure appropriate establishment, justification, and documentation of MACO (Maximum Allowable Carryover) limits.
• Assess validation impacts resulting from deviations, investigations, and process changes.

• Support the site's FDA and regulatory inspection readiness programs.
• Participate in mock inspections, compliance assessments, and gap analyses.
• FDA inspections
• Internal audits
• Assist with audit coordination, documentation requests, and back-room support activities.
• Support investigation reviews and compliance-related projects as needed.

This position operates in a combination of office, laboratory, and manufacturing environments. The role requires frequent interaction with Quality, Manufacturing, Validation, and Regulatory teams to…